Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients

Asan Medical Center1 site in 1 country27 target enrollmentNovember 2009

ConditionsRenal Insufficiency Kidney Diseases Urologic Diseases

InterventionsUdenafil

DrugsUdenafil

Overview

Phase: Phase 1
Intervention: Udenafil
Conditions: Renal Insufficiency
Sponsor: Asan Medical Center
Enrollment: 27
Locations: 1
Primary Endpoint: Pharmacokinetics (AUC and Cmax)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to assess the effect of renal impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with renal impairment compared to healthy subjects.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

November 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

•Adult males aged 19 to 64 years at screening.
•Subjects with body weight ≥ 55 kg and within ±30% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.
•Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria

•Subjects with the test results of QTc \> 430 ms or non-sinus cardiac rhythm by ECG analysis.
•Subjects with hypotension or hypertension.
•Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
•Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.